Prescription medication · Opioid / Norepinephrine Reuptake Inhibitor
tapentadol
Also sold as Nucynta. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Data updated 2026-05-15
- 33,054
- FDA reportsModerately reported
- 16
- InteractionsSeveral interactions
- $15.80
- Brand price (NADAC)
What the data shows
tapentadol (Nucynta) is a prescription Opioid / Norepinephrine Reuptake Inhibitor, reported at a middle-of-the-pack volume (33,054 FDA reports), with 16 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tapentadol (Nucynta) is a prescription Opioid / Norepinephrine Reuptake Inhibitor. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Nucynta is a strong pain medicine. It is used to treat severe acute pain when other pain medicines are not strong enough.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$15.80/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds).
Common side effects
Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting)
Key warnings
Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death.
The sections below are summarized in plain English from tapentadol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Nucynta works in two ways to relieve pain. It acts on opioid receptors in the brain to reduce pain signals. It also prevents the reuptake of norepinephrine, which can also help reduce pain.
How to Take It
Take Nucynta exactly as your doctor tells you. You can take it with or without food. Your doctor will prescribe the lowest dose that works for you, for the shortest time needed. Do not change your dose without talking to your doctor.
This is a plain-language summary of tapentadol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using Nucynta for a long time during pregnancy can cause withdrawal symptoms in the newborn. Talk to your doctor about the risks if you are pregnant or plan to become pregnant. If you are breastfeeding, monitor your baby closely for any signs of drowsiness or breathing problems.
This is a plain-language summary of tapentadol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of tapentadol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Nucynta at room temperature (68°F to 77°F) in a safe place, protected from moisture and out of reach of children.
Side Effects (from patient reports)
Based on 33,054 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tapentadol, by number of reports
- Death
Death
11,543 reports
- Harm from drugs or chemicals
Harm from drugs or chemicals
9,292 reports
- Took too much medicine
Took too much medicine
5,817 reports
- Misusing medicine 1,414
Misusing medicine
1,414 reports
- Need for the drug 977
Need for the drug
977 reports
- Baby has withdrawal symptoms from mother's medicine 932
Baby has withdrawal symptoms from mother's medicine
932 reports
- Took too much medicine by accident 656
Took too much medicine by accident
656 reports
- Pain 602
Pain
602 reports
- Feeling sick to your stomach 520
Feeling sick to your stomach
520 reports
- Purposely misusing the medicine 362
Purposely misusing the medicine
362 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for tapentadol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where tapentadol sits
tapentadol has more FDA adverse-event reports than 66% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is tapentadol; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 33,054 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.
Total Reports
33,054
Reports Mentioning Death
20,529
62.1% of reports — not proof of cause
Hospitalization Reports
4,458
Top Indication
Pain
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEATH | 11,641 |
| 2 | TOXICITY TO VARIOUS AGENTS | 9,719 |
| 3 | OVERDOSE | 5,886 |
| 4 | DRUG ABUSE | 1,549 |
| 5 | DRUG DEPENDENCE | 1,063 |
| 7 | DRUG WITHDRAWAL SYNDROME NEONATAL | 944 |
| 8 | PAIN | 743 |
| 9 | NAUSEA | 713 |
| 10 | ACCIDENTAL OVERDOSE | 705 |
| 11 | FATIGUE | 433 |
| 12 | HEADACHE | 408 |
| 13 | DIZZINESS | 403 |
| 14 | INTENTIONAL PRODUCT MISUSE | 398 |
| 15 | SOMNOLENCE | 386 |
| 16 | VOMITING | 382 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Nucynta can cause addiction, abuse, and misuse, which can lead to overdose and death. Your doctor will check your risk before prescribing and regularly during treatment. This medicine can also cause life-threatening breathing problems, especially when you start taking it or after a dose increase. Taking Nucynta with benzodiazepines (like Xanax or Valium), alcohol, or other CNS depressants can cause sleepiness, slowed breathing, coma, and death. Accidental ingestion, especially by children, can cause a fatal overdose. If you are pregnant and use Nucynta for a long time, your baby could have withdrawal symptoms after birth.
Known Drug Interactions
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and...
Mechanism: Taking these drugs together increases the risk of dangerous slowing of your breathing. They can also cause a serious buildup of a brain chemical called serotonin.
What to do: Use these medications together only if your doctor determines it is necessary. Monitor closely for extreme sleepiness or trouble breathing.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and...
Mechanism: Both of these medications can slow down your breathing and affect your brain's serotonin levels. Combining them makes these side effects more likely and more severe.
What to do: Your healthcare provider should monitor you closely for signs of respiratory distress. Avoid this combination unless specifically directed by your doctor.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: Combining these can lead to a toxic level of serotonin or a sudden rise in blood pressure. Both drugs increase chemicals in your system that can cause these serious side effects.
What to do: You should generally avoid taking these two drugs at the same time. If you must use both, your doctor will need to watch your health very carefully.
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol.
Mechanism: Both drugs are sedatives that slow down your brain and nervous system. Taking them together can make you feel very sleepy or make it hard to breathe.
What to do: Use this combination with caution and watch for signs of extreme drowsiness or slow breathing.
Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Mechanism: Both medications increase a brain chemical called serotonin. If serotonin levels get too high, it can cause a serious medical problem called serotonin syndrome.
What to do: Watch for signs like confusion, sweating, or muscle shakes, and tell your doctor immediately if you notice these symptoms.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I stop taking Nucynta suddenly?
Can Nucynta cause constipation?
Is Nucynta a strong painkiller?
Can I drink alcohol while taking Nucynta?
What should I do if I think I have taken too much Nucynta?
Can Nucynta make me feel sleepy?
Will Nucynta interact with my other medications?
How often can I take Nucynta?
Can Nucynta be used for long-term pain?
Is Nucynta addictive?
What are the common side effects of tapentadol?
Does tapentadol interact with other medications?
What drug class is tapentadol?
Is tapentadol safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for tapentadol
The FDA label for tapentadol (sold under brand names such as Nucynta) classifies it as a prescription-only medication in the Opioid / Norepinephrine Reuptake Inhibitor class. Nucynta is used to manage acute pain in adults and children (6 years and older weighing at least 88 pounds). Official labeling lists 4 commonly reported side effects, including Feeling sick to your stomach (nausea), Feeling dizzy, Throwing up (vomiting).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 33,054 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 30, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages